BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EVOLUTION SPINE, LLC

    Reg #: 3012428435 · FEI: 3012428435 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    11
    Establishment Types
    4
    Classifications
    8

    Registration Details

    Registration Name
    EVOLUTION SPINE, LLC
    Registration Number
    3012428435
    FEI Number
    3012428435
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2300 N Haskell Ave
    City
    Dallas
    State
    TX
    ZIP
    75204
    Country
    US

    Regulatory Submissions

    510(k) Number
    K260038

    Owner / Operator

    Firm Name
    Evolution Spine, LLC
    Operator Number
    10051848
    Address
    2300 N Haskell Ave
    City
    Dallas
    State
    TX
    Postal Code
    75204
    Country
    US
    Correspondent
    Ashton Kouzbari

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Thoracolumbosacral Pedicle Screw System NKB
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    E3D-C Interbody System Vail ALIF Buttress Plate System EMERGE Anterior Cervical Plate System Skye Cervical Plate System Stowe Pedicle Screw System E3D-A Interbody System Evolution Spine Navigation Instruments Evolution Spine Cervical Interbody Fusion System Evolution Spine Interbody System Whistler Modular Pedicle Screw System E3D™-A Interbody System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device